BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 10245050 · Received July 8, 2020

    Report

    Report Number
    3005290010-2020-00014
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 8, 2020
    Manufacturer
    MILTENYI BIOTEC B.V. & CO. KG
    Product Code
    OVG
    UDI-DI
    04049934004827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED A LOW ELUTION VOLUME AND LOW RECOVERY OF A CD34 SEPARATION. THE PATIENT COULD NOT BE TREATED. TO OUR INFORMATION IT WAS CONSIDERED TO RE-COLLECT THE DONOR TO REPEAT THE CD34 SEPARATION. AS THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE REAGENT, A COMPLAINT RATE COULD NOT BE CALCULATED. HOWEVER, SUCH INCIDENTS ARE VERY RARE. AN ANALYSIS OF THE PROCESS CODE SHOWED THAT THE PROCESS WAS FINISHED WITHOUT ERROR CODES. HOWEVER, THE SAMPLE LOADING TIME WAS UNUSUALLY HIGH AND THE VOLUMES AFTER SEPARATION DID NOT FIT THE EXPECTED RANGE. THE CUSTOMER INDICATED THAT THE FLUID PATHWAY MIGHT HAVE BEEN PARTIALLY BLOCKED. THIS EXPLAINS OR AT LEAST CONTRIBUTED TO THE LOW VOLUME AND LOW RECOVERY. THE HIGH LOADING TIME IS PROBABLY DUE TO SAMPLE MATERIAL OLDER THAN RECOMMENDED AND VALIDATED (41H VS. 24H). THIS INCREASES THE RISK FOR AGGREGATES WHAT AGAIN HAS INFLUENCE ON THE ELUTION VOLUME AND RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709142 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT OVG MILTENYI BIOTEC B.V. & CO. KG 70103 UNKNOWN 04049934004827

    Patients

    Seq Age Sex Outcome Treatment
    1